1. Field of the Invention
The present invention relates generally to the field of medical devices and surgical instruments, and more specifically to the field of devices and systems for dressing and closing a laceration or incision.
2. History of the Related Art
Compositions and methods for laceration or incision closure are known in the art. The use of sutures or staples to close a laceration or incision represents the most common of these prior art techniques. The use of sutures or staples is an invasive technique that can be painful and frequently requires the use of an anesthetic. These procedures often leave unsightly scars, both from the secondary insertion holes as well as spacing and depth variations that result in varying tensions applied to the laceration or surgical incision between the suturing points and intervening spaces. Moreover, these skin closure techniques necessitate follow-up visits to a hospital or doctor's office for removal.
Alternative means for laceration closure have been previously disclosed, for example in U.S. Pat. No. 4,423,731 to Roomi, issued in 1984. The Roomi invention included a surgical dressing consisting of two strips of adhesive plaster placed in parallel about a wound edge. A series of filaments attached to each plaster strip, which are selectively attachable across the breadth of the wound to two additional plaster adhesive strips that were placed outside the former pair. Tension applied to the outer strips caused the inner strips to approach each other, thus placing pressure on the skin about the wound and effectively closing it.
While the Roomi invention was a step forward in the design of surgical dressings, it nevertheless contained several design problems. As pointed out in U.S. Pat. No. 5,534,010 to Peterson, the Roomi device needed improvement in two areas. First, according to Peterson, the Roomi device did not have a sufficient number of filaments and would better draw the wound together with more filaments: additionally a large number of threads would apply pressure against the wound similar to an adhesive pad which Peterson claims promotes healing. Secondly, the Peterson patent argues that the Roomi device is inefficient because it attaches the filaments to the side of the outside adhesive strips, as opposed to the end of the inner strips that would allegedly provide greater tension across the wound itself. In summary, the Peterson device is predicated in part upon the supposition that the Roomi device is improperly configured for high-tension applications, which are arguably necessary in areas of high vascular concentration.
Like the Roomi device, the Peterson invention includes a series of four flat tape strips that are joined together by interlaced filaments that span a wound to be closed. The Roomi & Peterson patents suffer from a number of serious deficiencies. The first deficiency is the failure to secure the two tape strips adjacent to the wound from lateral movement relative to each other once the device is closed. While the filaments may be effective at preventing the strips from parting outward they are not secure relative to each other along the wound edge. The Roomi patent requires long filaments as the attaching strips fall beyond the opposing pads. The Peterson patent while having shorter filaments teaches a series of filaments that do not attach to the respective tape strips at or near the wound site. Elementary geometry teaches us that the stability of any device of this type will depend highly on the length that the filaments must traverse between fixed points. Given the geometry of the Peterson device, it is evident that the length of the filaments combined with the distance that they must span between fixed points renders the device relatively unstable. In particular, any shearing or torque movement of the bandage components that are attached to the wound edges will decrease stability of the bandage during healing. Accordingly, the Peterson invention leaves the user open to certain risks including the movement of the bandage components relative to each other directly adjacent to the wound itself.
The Peterson and the Roomi devices present further risks by leaving the filaments or crossing members exposed to potential snags or pulling. Exposed filaments are particularly susceptible to pulling, snagging or tearing when in contact with clothing or the user's daily wear. The Peterson patent teaches that a specific deficiency of the Roomi device was that it does not have enough filaments to generate the necessary tension. Accordingly, the Peterson device specifically teaches using up to twenty-six filaments per linear inch. The added number of filaments required in the Peterson device compounds the problem by vastly increases the risk that the device itself will become snagged and could dislodged from the user. As the Peterson device is not particularly stable about the wound site, this increase in the number of filaments only exacerbates these risks.
Finally, Peterson teaches that a large number of filaments is necessary to generate the tension necessary for certain applications, but there is little in existing surgical publications that lend credence to this claim. However, as the density of the filaments increases according to Peterson's teachings, the strips near the wound edges become increasingly difficult to adjust relative to each other during application. This is a serious problem as the strips can never be applied perfectly relative to one another and always require some lateral adjustment. If there is not enough adjustability the wound could be closed in a bad position. Adjustability is feature that improves with fewer filaments (opposite Peterson's teaching). As such, the applications suitable for the Peterson device are rather limited in scope. The Peterson device does not present a solution to the principal problem of the Roomi device, e.g. the lack of security of the device when closed; but rather proposes solutions to issues that are unimportant and have simply engendered another set of problems outlined above.
Liquid bandages and other adhesive-type compositions have also been used widely in the medical arts. These types of closures are generally best suited for superficial or minor wounds, as skin adhesives do not draw the skin together or align the edges. It is difficult to align the skin edges and compress a larger or deeper wound manually or with the use of forceps, which is required to apply a liquid adhesive to the wound. In the case of liquid wound closure means, again that art is lacking in devices and methods that provide rigid dimensional stability in combination with precision alignment of the wound edge and maintenance of the healing process. Although these and other compositions and methods for closing wounds or incisions are known in the art, the aforementioned problems have prevented them from gaining popular acceptance. While there is a clear need for a minimally invasive composition or method for wound or incision closure that is practical and easy to use, such a composition or method must retain its dimensional stability after being secured in order to prevent any additional trauma to the wound while simultaneously being readily adjustable and adaptable for different wound closure applications.